The following data is part of a premarket notification filed by Polymint Industrial Co. Ltd. with the FDA for Sambord Latex Patient Examination Gloves.
| Device ID | K891644 |
| 510k Number | K891644 |
| Device Name: | SAMBORD LATEX PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | POLYMINT INDUSTRIAL CO. LTD. 1-56, HSIN CHUANG TZAE LANE CHUNG SHA RD., LUNG CHING Hsiang, Taichung Hsien, TW |
| Contact | Chan-long Lin |
| Correspondent | Chan-long Lin POLYMINT INDUSTRIAL CO. LTD. 1-56, HSIN CHUANG TZAE LANE CHUNG SHA RD., LUNG CHING Hsiang, Taichung Hsien, TW |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-17 |
| Decision Date | 1989-06-19 |